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Aneroid Sphygmomanometer with Stethoscope

by Wenzhou Longwan Medical Device Factory

510(k) K240165

Active European Union and United States

CE MDR CE MDD 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K240165↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK240165 Date20 Mar 2024ClearedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD, CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

Full name
Aneroid Sphygmomanometer with Stethoscope; Aneroid Sphygmomanometer
510(k) Number
FDA Product Code
DXQ
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 870.1120
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

An aneroid sphygmomanometer with stethoscope is a medical device used for measuring blood pressure. It consists of an aneroid gauge and a stethoscope for detecting Korotkoff sounds during blood pressure measurement.

The device is supplied by Wenzhou Longwan Medical Device Factory and is authorized under FDA 510K, MDD, and MDR regulations. It is designed for clinical settings and is available in various models with specific reference codes as indicated in the product specifications.

From the manufacturer

Manufacturer's product page: Aneroid Sphygmomanometer

Other devices from Wenzhou Longwan Medical Device Factory

See all devices from Wenzhou Longwan Medical Device Factory →

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the purpose of the Aneroid Sphygmomanometer with Stethoscope?

    This device is used for measuring blood pressure by detecting Korotkoff sounds through its aneroid gauge and stethoscope components, making it suitable for clinical settings.

  • How is the Aneroid Sphygmomanometer supplied?

    The device is supplied by Wenzhou Longwan Medical Device Factory and is available in various models with specific reference codes as indicated in the product specifications.

  • What regulatory approvals does this device have?

    The device is authorized under FDA 510K, MDD, and MDR regulations, indicating it meets regulatory requirements for these markets.

  • Is the Aneroid Sphygmomanometer single-use or reusable?

    The device data does not specify whether it is single-use or reusable, so this information would need to be obtained directly from the manufacturer.

  • What sizes and models are available for this device?

    The device is available in various models with specific reference codes as indicated in the product specifications, though the exact sizes and models are not detailed in the provided data.